Official recall notice
FDA DeviceClass IINotable
FDA Recall: Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
- Recall date
- 2026-07-08
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Product description
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Affected products
UDI: (01)04049539101563 Batch no: A0002 Serial numbers: US - A63141, A63086 OUS (Outside the US) - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313